SOPs and Forms

Description: SOPs related to the membership and composition of the UPCHE REC

• SOP 1 Selection and Appointment of REC Members

• SOP 2 Designation of REC Officers

• SOP 3 Designation of an Independent Consultant

Description: SOPs related to the review process of the UPCHE REC

• SOP 4 Management of Initial Submission

• SOP 5 Management of Protocols Exempted from Review

• SOP 6 Expedited Review

• SOP 7 Full Review

• SOP 8 Management of Resubmission

• SOP 21 Communicating REC Decisions

• SOP 28 Management of Appeals

Description: SOPs related to the review of various reports during post-approval monitoring of approved protocols

• SOP 9 Management of an Application for Continuing Review

• SOP 10 Review of Progress Report

• SOP 11 Protocol Amendment Review

• SOP 12 Management of Protocol Deviation

• SOP 13 Review of SAE, SUSAR, and RNE Report

• SOP 14 Review of Early Termination Report

• SOP 15 Review of Final Report

• SOP 16 Conduct of Site Visit

• SOP 26 Management of Queries or Complaints

Description: SOPs related to the preparation and conduct of REC meetings

• SOP 17 Preparation for a Meeting

• SOP 18 Preparation of Meeting Agenda

• SOP 19 Conduct of Meetings

• SOP 20 Preparation of Minutes of Meetings

Description: SOPs related to the procedures for documentation and archiving of protocol and related files

• SOP 22 Management of Incoming & Outgoing Communications

• SOP 23 Management of Active Files

• SOP 24 Archiving of Documents

• SOP 25 Management of Access to Confidential Files

Description: SOPs related to the review and revision of the UPCHE REC SOPs

• SOP 27 Writing and Revising Standard Operating Procedures

Other Policies and Guidelines

• Policies for student, faculty and REPS research protocols

• Policies and guidelines for Application of ethics clearance outside of UPCHE REC

• Policies and guidelines for Research Involving Secondary Data